Institutional Biosafety Committee Application Form – Instructions
What is the Institutional Biosafety Committee Application Form?
As a major research institution, the University Missouri (MU) provides assurance that its sponsored research activities are in compliance with federal, state, and local regulations and guidelines. The Institutional Biosafety Committee (IBC) Applicationis a document describing a Principal Investigator’s (PI’s) research at MU, and when approved by the IBC, provides authorization for you, the PI, to conduct that research.
Who must submit anIBC Application?
If your research involves:
- Microbiological agents infectious to humans and animals, including Select Agent Organisms Provide a copy of any required federal permit.
- Use of Human blood, body fluids, tissues, cell lines. Review OSHA guidelines Primate clinical specimens or cell lines; animals and their blood tissues and cell lines, for which a reasonable potential for transmission of zoonotic agents exists, e.g., wild-trapped animals, sheep and non-human primates. Review MU IBC Policy Statement on Human/Nonhuman Primate Cell Lines at
- Exotic plants, animals and microbes (e.g., nonindigenous plant or insect pathogens, or biological control agent); provide a copy of any required federal permit
- Toxins on the Select Agent list, when administered in vivo or in vitro to induce a biological outcome
- Recombinant DNA materials or technology, that are subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules located at including human gene transfer and transgenic animals and plants. Some lower level rDNA research may be EXEMPT and not require MU Institutional Biosafety Committee review or approval. Researchers should contact the MU Biosafety Office at 882-7018 to discuss steps to request an exemption letter. Review MU IBC Policy Statement on Transgenic Animals at IBC Policy Statement on Transgenic Plants at
- All biohazardous material, Biosafety Level 2 (BSL-2) or higher research actives as described in Section 2.4 of the MU Biosafety Manual .
General Information for Submission of IBC Application
Content: A single IBC application from a PI may cover multiple research activities. Applications for recombinant or synthetic nucleic acid molecules and/or BSL-2 or BSL-3 research require review and approval at an IBC meeting.
Submission Assistance: Prior to submitting hard copies of an application, it is strongly recommended the PI forward an electronic version for MU biosafety staff review and assistance to make a successful IBC application. The electronic version should be sent as early as possible to allow sufficient time for administrative review, feedback, and changes prior to IBC protocol submission deadline.
If you have technical problems with the form (e.g. the checkboxes don’t work on your computer, you can’t “cut and paste”, etc.), please contact the Biological Safety Program staff at .
Application Preparation: Please make sure the application is complete and free of typographical and grammatical errors. Attach additional items that will aid committee members during the review process: e.g., specific vector(s) and plasmid(s) information, cell lines, ATCC product description, etc.
Deadlines and IBC Review Dates: Protocol submission deadline dates and IBC meeting dates are posted at Only administratively complete applications received by NOON on the submission deadline date will be considered at the next scheduled IBC meeting.
Duration of Approved Protocols: 3 years.
Laboratory Facility Safety Review
A complete application and maintenance of an active protocol require a laboratory facility safety review of the designated research area by a member of the Department of Environmental Health & Safety (EHS) staff to ensure the recommended controls and containment level are appropriate for the proposed research. EHS staff, IBC Chair, and additional IBC members may participate in the laboratory facility safety review. The PI or laboratory staff member with a comprehensive knowledge of the proposed work must be present during the review. Reviews are performed at a minimum, prior to review of the initial application and annually during the 3 year approval period for human gene therapy studies, Select Agent, and biosafety level 2 & 3 research. Lower level research laboratories are reviewed during the triennial protocol renewal process. Any biosafety concerns identified during this review will be discussed with the PI. Any unresolved items will be forwarded to the IBC for discussion or corrective action. The BSP and any IBC member can request a facility review, regardless of the biosafety level assigned, at any time throughout the approved period. PIs and research staff are encouraged to conduct biosafety self-audits for their laboratories, using checklists available in the MU Biosafety Manual or from the BSP.
How to Modify Approved IBC applications
Changes in protocol name, animal species, animal housing, biosafety cabinet, individual rooms, research personnel, cell lines, time of research project, and deletion of biohazardous material: These are reviewed by theIBC Chairperson and Biosafety Personnel (BSP). Approval of changes should be requested using the Institutional Biosafety Committee Application Amendment These are administrative reviews and will be conducted using the Biosafety Protocol Information On-Line Renewal System.
Changes in biosafety level, laboratory move, animal handling process, PI, addition ofbiohazardous material, procedures, or in vitro to animal use: These require amending the IBC Application and require full IBC review and approval. A current approved IBC application can be provided for PI review and update by sending an email request to .
PI Responsibilities
It is the PI’s responsibility to notify the IBC of any changes in their ACUC protocol that involve recombinant or synthetic nucleic acid molecule or additional biohazardous materials not listed on the current IBC approved protocol.
If you have questions regarding the Institutional Biosafety Committee Amendment Application please contact MUEnvironmental Health & Safety (EHS) Biological Safety Program at 882-7018 or by email at .
Completing the Institutional Biosafety Committee Application Form
Grayed Areas for IBC Use Only
PAGE 1User Registration # (upper right) / Investigator 4-digit User RegistrationNumber assigned to a researcher by MUEHS. If you have already been assigned an RU number, please indicate it here. This number is not required at the time of application but should be established prior to final approval of the IBC application. Apply for a Registered User number at
1 Protocol Title / Please provide a title that clearly describes the scope of work. Please do not use acronyms. Grant titles tend to be vague and do not clearly provide a general description of the research. EXAMPLE: “The role of BclA in resistance to apoptosis” is less informative to the IBC than “Infection of primary human endothelial cells with adenoviral vectors expressing human BclA protein”.
2 Principal & Co-Investigator / The application provides space for a PrincipalInvestigator and Co-Investigator (if needed). This information will be used to contact the researcher(s) and address any correspondence from the IBC. Additional collaborators may be listed in Question #8 “Laboratory Personnel”.
3 Application Type / Check the appropriate box.
New—New research protocol application.
Amendment—Change request for a protocol <3 years old.
NOTE: Form is available for administrative changes requiring onlyIBC
Chair and BSP approval Go to
to see if your changequalifies for a one page amendment.
Renewal—Periodic review required every three years. This is a full update of the application by the PI for IBC review/approval.
4 Dates of Proposed Research / Provide a proposed start and end date for this research protocol based on anticipated funding and research timeline.
5 Primary Research Locations & Multi-User Locations / List all laboratory room numbers where biohazardous or recombinant or synthetic nucleic acid molecule research will be conducted. If you are aware of the Biosafety Level for the room, note it on the form, if not aware of the biosafety level leave the field blank and the BSP will assign the level following an inspection of the location. If the room is used by other investigators, check the “Shared Room” box. Include multi-user areasfor: autoclave, centrifuge, incubator, PCR equipment, etc. NOTE: Use Item #6 to record material storage locationsand biosafety cabinet locations. Use Item #7 to record animal housing and procedure locations.
NOTE: The University of Missouri has a memorandum of understanding that identifies the Institutional Biosafety Committee as the designated IBC for recombinant or synthetic nucleic acid molecule research conducted at the Harry S. Truman Memorial Veterans Hospital. You must clearly identify all MU and VA research locations on the IBC protocol application. MU Biosafety Staff will work with investigators to clearly identify research at each facility.
6 Research Storage and Biosafety Cabinet Locations / List the room numbers where the material will be stored and the type of containment (IE: locked -80 freezer, liquid nitrogen dewer, chiller, sealed plastic container, sealed cardboard container, etc).Also include biosafety cabinet locations where material will be used. If the room is used by other investigators, check the “Shared Room” box. Mark the “Secured” box to indicate your materials are properly secured. If you have questions regarding security, contact MU Biosafety staff 882-7018 or via email .
Note: Biological Safety Cabinets (BSCs) are required by the IBC when reviewing BL2 and BL3 protocol request. For BL2 and BL3 IBC approved research biological safety cabinets must be certified annually and must have a biohazard identification sticker posted on the cabinet. Contact MU Biosafety staff via email for information on the current vendor contracted to provide annual biosafety cabinet recertification. The Department of Environmental Health & Safety works with MU Procurement Services every three years to maintain a preferred pricing vendor contract for biosafety cabinet recertification.
7 Research Animal/Plant Locations / List the type of animal or plant,room location,farm or environmental study sites where animals or plants will be housed or where animal surgical procedures will be conducted. If you are aware of the Biosafety Level, note it on the form, if not aware of the biosafety level leave the field blank and the BSP will assign the level following an inspection of the location. If the room is used by other investigators, check the “Shared Room” box.
8 Research Personnel / The PI must be first on the personnel listing, followed by co-investigators and other laboratory personnel. All workers involved in the work must be listed, including collaborating researchers, staff, post-docs, student workers, and volunteers.All laboratory staff must be at least 16 years of age and workers 16-18 years of age must be clearly identified for the MU IBC. Committee members will discuss agents in use in the PI laboratory and specific activities the worker will be involved in. Check the checkbox for each training requirement that applies to research activities noted on the protocol document as well as the date the training was last completed:
- Introduction to Biosafetyis required initially and every three years for staff listed on BL2 or BL3 containment protocols(if you checked BL-2 or BL-3 on question #11).
- Recombinant DNA Training is required initially and every three years for staff listed on protocols involving research with recombinant or synthetic nucleic acid molecules (if you completed any question in #10b.i.-#10.b. vii.).
- Bloodborne Pathogenis required initially and annually for all staff with potential exposure to human blood, tissues, cell lines (if you checked “Yes” on question #10.i.). This annual training is required under the OSHA Bloodborne Pathogens Standard 29CFR 1910:1030.
You may review training records for laboratory personnel by going to Enter the Employee ID or Student ID and Last Name and choose “Log In”. The following screen will allow you to choose “Training History Record”. If you have questions regarding training, contact MU Biosafety staff 882-7018 or via email .
9 Research Core Facility / List the name of the MU Research Core Facility, building where the facility is located and the name of the Core Director. EHS will review approved protocols for the core facility’s IBC protocol approval number.
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10.a. Use of biohazardous or rDNA material from a non MU collaborator? / If NO go to 10b. NOTE: If material is supplied by another MU researcher, please provide information in question #9 or 13C of this application.
If YEScomplete question 10.a.i.
10.a.i. Provide the non MU collaborator’s name and research institution/facility.
Provide additional information about the material to be received in question #13C “Description of experimental procedures”. Include the following items:
- Are you providing material to the researcher and that researcher is returning a recombinant plant or animal?
- Are you receiving viral vectors? What type/strain?
- Request email confirmation from the researcher supplying the material that his/her research is approved by the IBC of their institution. Please forward this information along with your protocol application.
10.b. Use of Recombinant or synthetic nucleic acid molecules? / See NIH definition of Recombinant or Synthetic Nucleic Acid Molecules at
If NO go to 10.c.
If YES complete questions 10.b.i. – 10.b.viii.
10.b.i. Provide listing of source(s) of cloned or synthetic molecules and how obtained.
10.b.ii. Provide listing of inserted or synthetic molecules. Include identification by name of the biological source (e.g., structural genes, oncogenes,reporter genes, resistance genes, etc). If the sequence encodes antibiotic resistance (indicate specific antibiotic) or toxin.
10.b.iii. List phage vector(s) used inthis research. Be as specific as possible. If additional space is required, attach additional documents.
10.b.iv.List plasmid vector(s) or replicon used: (Indicate if conjugative)
10.b.v. List viral component(s) sequence(s) present. Include risk assessment for the viral vector (example: replication deficient vector) indicating how viral vector has been rendered replication incompetent.
10.b.vi. Provide ALL host information: bacteria, virus, and animal or human cell lines or subjects.
NOTE: The use of non-K12 E. coli hosts falls within the NIH guidelines and requires MU Institutional Biosafety Committee review. Use of K-12 E. coli hosts may be exempt but requires initial application to the MU Biosafety Staff for review.
10.b.vii.If YES
(a) Describe the protein to be produced.
(b) Explain possible toxicity or other hazards of the foreign protein.
10.b.viii. NIH Experiment Type see definitions at
NIH requires the researcher identify the section of the NIH Guidelines that apply to this research. Contact EHS for assistance or 882-7018.
NOTE: The following sections of the NIH Guidelines require either NIH Recombinant DNA Advisory Committee (RAC), NIH Office of Biotechnology Activities, or specialized MU Institutional Biosafety Committee review. If your proposed research falls into one of the following guidelines, contact EHS for additional information (statements below are not complete, see NIH Guidelines for full text):
§ III-A-1 The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the ability to control disease agents in humans, veterinary medicine, or agriculture will be reviewed by the RAC.
§ III-B-1 Experiments involving the cloning of toxin molecules with LD50 of less than 100 nanograms per kilogram body weight.
§ III-B-2 Experiments that have been approved (under section III-a-1-a) as Major Actions under the NIH Guidelines
§ III-C-1 Experiments involving the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant synthetic nucleic acid molecules, into one or more human research participants.
§ III-D-1-a Experiments involving the introduction of recombinant or synthetic nucleic acid molecules into Risk Group 2 agents.
§ III-D-1-b Experiments involving the introduction of recombinant or synthetic nucleic acid molecules into Risk Group 3 agents.
§ III-D-1-c Experiments involving the introduction of recombinant or synthetic nucleic acid molecules into Risk Group 4 agents.
§ III-D-1-d Containment conditions for experiments involving the introduction of recombinant or synthetic nucleic acid molecules into restricted agents.
§ III-D-2-a Experiments in which DNA from Risk Group 2 or 3 agents is transferred into nonpathogenic prokaryotes or lower eukaryotes.
§ III-D-2-b Containment conditions for experiments in which DNA from restricted agents is transferred into nonpathogenic prokaryotes or lower eukaryotes shall be determined by NIH/OBA following a case-by-case review.
§ III-D-3-a Experiments involving the use of infectious or defective Risk Group 2 viruses in the presence of a helper virus.
§ III-D-3-b Experiments involving the use of infectious or defective Risk Group 3 viruses in the presence of a helper virus.
§ III-D-3-c Experiments involving the use of infectious or defective Risk Group 4 viruses in the presence of a helper virus.
§ III-D-3-d Experiments involving the use of infectious or defective restricted poxviruses in the presence of a helper virus.
§ III-D-3-e Experiments involving the use of infectious or defective viruses in the presence of helper virus which are not covered in Section III-D-3-a through III-D-3-d.
§ III-D-4-a Recombinant or synthetic nucleic acid molecules or DNA or RNA molecules derived therefrom, from any source except for greater than two-thirds of eukaryotic viral genome may be transferred to any non-human vertebrate or any invertebrate organism. (Experiments in whole animals)
§ III-D-4-b Experiments involving recombinant or synthetic nucleic acid molecules or DNA or RNA derived therefrom, involving whole animals, including transgenic animals, and not covered in § III-D-1.
§ III-D-5-(a-e) Experiments involving whole plants not listed in Section III-E-2. Section III-D-5 involves exotic plants with a biocontainment requirement of BL2-P+, BL3-P, or BL4-P.
§ III-D-6 Experiments involving more than 10 liters of culture.
§ III-D-7-(a-d)Experiments with influenza viruses generated by recombinant or synthetic methods (e.g., generation by reverse genetics of chimeric viruses with reasserted segments, introduction of specific mutations) shall be conducted at the biosafety level containment corresponding to the Risk Group of the virus that was the source of the majority of segments in the recombinant or synthetic virus (e.g., experiments with viruses containment a majority of segments from a RG2 virus shall be conducted at BL3). Experiments with influenza viruses containing genes or segments from 1918-1919 H1N1 (1918 H1N1), human H2N2 (1957-1958) and highly pathogenic avian influenza H5N1 strains within the Goose/Guangdon/96-like H5 lineage (HPAI H5N1.